QC Reviewer/Assistant Manager/Manager

We are seeking a dynamic and experienced Quality Control (QC) Manager to lead and manage QC operations, ensuring that products and processes meet stringent quality and regulatory requirements. The ideal candidate will possess deep technical expertise, a strong leadership background, and a commitment to data integrity and continuous improvement within the life sciences industry.

A detail-oriented professional with expertise in Nitrosamines/NDSRI method development and validation by LC-MS focused on detecting and quantifying nitrosamine impurities in APIs and Finished Dosage Forms. You will contribute to method development, validation, instrument calibration, and document preparation while ensuring compliance with safety, regulatory, and cGLP standards.

Preferred Manager profile:

• Design and implement robust QC procedures aligned with current Good Manufacturing Practices (cGMP) and industry standards.
• Ensure processes are optimized for efficiency, accuracy, and compliance.
• Regularly assess QC operations and procedures.
• Identify opportunities for improvement and implement enhancements to streamline workflow and ensure regulatory readiness.
• Ensure QC operations comply with global regulatory authorities including USFDA, EDQM, ANVISA, PMDA, and WHO.
• Maintain audit readiness and lead/support regulatory inspections.
• Team Leadership and Development
• Manage and mentor a team of QC professionals, ensuring high performance and ongoing professional development.
• Assign responsibilities, monitor progress, and promote a culture of accountability and collaboration.
• Data Integrity and Documentation
• Ensure accuracy, reliability, and confidentiality of all laboratory records and data.
• Enforce adherence to ALCOA+ principles for data integrity.
• Troubleshooting and CAPA Management
• Investigate quality-related issues, perform root cause analysis, and lead implementation of effective corrective and preventive actions (CAPAs).
• Cross-functional Collaboration
• Collaborate with AR&D, QA, and other departments to align quality strategies.
• Communicate quality metrics, performance, and issues to leadership and stakeholders.
• Quality System Contributions
• Support development and implementation of quality management systems (QMS).
• Review and approve analytical methods, validation protocols, and reports.
• Audit and Complaint Management
• Lead or support internal and external audits.
• Manage customer complaints and conduct trending analysis to drive quality improvements.

• Technical Skills:

• Hands-on experience and data interpretation of analytical instruments like LCMS, HPLC, GC,UV, KF, etc.

• Thorough understanding of cGMP, GLP, and regulatory requirements.
• Good documentation and analytical skills.

Job Description: QC Data Review Specialist

Job Summary

We are seeking a meticulous and highly organized QC Data Review Specialist to join our Quality Control team. The successful candidate will be responsible for the comprehensive GMP (Good Manufacturing Practices) review of laboratory raw data, analytical reports, and related documentation. This role is critical to ensuring that all laboratory work is performed in compliance with established methods and protocols, that results are analytically sound and accurate, and that all documentation adheres to stringent GMP standards and regulatory requirements.

Key Responsibilities

Data and Document Review: Conduct detailed reviews of analytical data packages, including but not limited to raw data (e.g., chromatograms, spectra), laboratory notebooks, and summary reports for accuracy, completeness, and compliance with GMP.

Compliance Verification: Ensure all testing was performed according to approved SOPs, analytical methods, and protocols. Verify that calculations and data transcriptions are correct and that any deviations or out-of-specification (OOS) results are properly documented, investigated, and reported.

Method Validation Review: Review method validation/verification/transfer protocols and reports to ensure they meet regulatory and company standards.

Stability Program Support: Review stability testing data and reports, ensuring that data integrity is maintained throughout the stability study lifecycle.

Audit Trail Review: Perform audit trail reviews of electronic data systems to ensure data integrity and identify any potential compliance risks.

Documentation Management: Assist in the revision and approval of controlled documents such as SOPs, test methods, and specifications.

Communication: Collaborate closely with laboratory analysts to resolve documentation errors, clarify discrepancies, and provide constructive feedback to prevent future issues. Act as a liaison between the QC laboratory and the Quality Assurance (QA) department.

Continuous Improvement: Identify gaps in procedures and opportunities for improvement within the laboratory data review process to enhance efficiency and compliance.

Qualifications

Education: Bachelor of Science (B.S.) degree in Chemistry, Biology, Biochemistry, or a related life sciences field is required.

Experience:

A minimum of 3-8 years of hands-on experience in a GMP-regulated pharmaceutical or biotechnology laboratory environment.

Direct experience in reviewing analytical data (e.g., HPLC, GC, UV-Vis, FTIR, wet chemistry) is essential.

Prior experience in a dedicated data review or QA role is highly preferred.

Knowledge:

In-depth knowledge of GMP, GDP (Good Documentation Practices), and data integrity principles.

Strong understanding of FDA, ICH, and other relevant regulatory guidelines.

Familiarity with common laboratory software and electronic data systems (e.g., LIMS, Chromeleon, Empower).

Required Skills and Competencies

Attention to Detail: Exceptional ability to spot errors, inconsistencies, and deviations in complex technical documents.

Analytical and Critical Thinking: Strong ability to interpret scientific data and assess its validity and compliance.

Organizational Skills: Excellent time management skills with the ability to manage multiple review assignments and meet deadlines.

Communication Skills: Clear and effective written and verbal communication skills are necessary to articulate findings and collaborate with team members.

Problem-Solving: Proactive in identifying issues and working with the team to find compliant solutions.

Integrity: Must uphold the highest standards of quality and ethical behavior.

Teamwork: Ability to work effectively both independently and as part of a collaborative team.

Behavioral & Leadership Skills:

• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal abilities.
• Demonstrated ability to lead cross-functional teams and drive a culture of quality.

Why JanSat?
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As JanSat focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.